Health Care

A recall of heart and blood pressure medication for possible carcinogen gets expanded

How FDA drug recalls work

The U.S. Food and Drug Administration regulates the safety of drugs, but sometimes a problem arises that triggers a recall. Here's how the recall process works and what you should do if a medicine you use is recalled.
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The U.S. Food and Drug Administration regulates the safety of drugs, but sometimes a problem arises that triggers a recall. Here's how the recall process works and what you should do if a medicine you use is recalled.

Teva Pharmaceuticals’ April recall of blood pressure and heart medication losartan has been expanded by six bulk lots after the possibly cancerous impurity NMBA was found in the active ingredient.

As with the original recall of losartan potassium, the tablets were sold exclusively to California company Golden State Medical Supply. Golden State put the tablets into 30-count, 90-count and 1,000-count bottles for retail sale.

Another similarity: the NMBA (N-Nitroso-N-methyl-4-aminobutyric acid) was in one lot of active ingredient from Hetero Labs Limited, the source of several losartan, valsartan and irbesartan recalls over the last 11 months.

Also not changing is the FDA and the recalling company telling users that have the recalled drugs to keep using them until their doctor or druggist comes up with an alternative treatment course.

Golden State repackaged the six bulk lots into seven retail lots, each with an expiration date of 1/2020:

Lot No. GS017387, 50 mg tablets, 30-count and 1,000-count bottles

Lot No. GS017651, 50 mg tablets, 90-count bottles

Lot Nos. GS017042, GS017043, GS017044 and GS017541, 100 mg tablets, 90-count bottles.

Anyone with questions for Teva can call Inmar at 877-789-2065 or email tevarecalls@inmar.com.

Anyone with questions for Golden State Medical Supply can call 800-284-8633, email recalls@gsms.us or fax 805-437-7582.

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Since 1989, David J. Neal’s domain at the Miami Herald has expanded to include writing about Panthers (NHL and FIU), Dolphins, old school animation, food safety, fraud, naughty lawyers, bad doctors and all manner of breaking news. He drinks coladas whole. He does not work Indianapolis 500 Race Day.

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